Where the evidence changed the decision.
A selection of outcomes from work I have led across senior evidence and value roles, abstracted so the method and the result are clear while the organization and the asset stay confidential. Each one turns on the same discipline: building the evidence to the standard the decision will apply, before the decision is made.
Selected Outcomes
A positive national HTA determination, ahead of plan.
Challenge
A specialty medicine faced appraisal by a national health technology assessment body, where the comparative-evidence bar was high and the questions the appraisal would ask could have resulted in a protracted multi-round review.
Approach
I built the case to be answered before it was questioned. We anticipated the body's concerns, were transparent about where uncertainty genuinely lived, drew on precedent and the strongest available methods, including ones adapted from other therapy areas, and partnered with leading external experts. I drove every analytic set, research partner, and strategic call, some of them unpopular. The posture was the opposite of the usual one: nothing hidden, nothing downplayed, the hard questions met head-on.
Outcome
After the body's initial questions were addressed, the appraisal moved straight to a positive final determination with nothing left to ask. Patients reached access roughly seven months ahead of plan, which protected the launch runway and the access position that followed.
Integrated evidence planning, rebuilt to work across an organization.
Challenge
A global organization had adopted integrated evidence planning in principle, but in practice the plans were over-engineered and inconsistent, laborious to produce and slow to drive the decisions they were meant to serve.
Approach
I led the initiative to make integrated evidence planning work across the organization. I diagnosed why the plans were failing, reset the standard from exhaustive documentation to strategic clarity and decision-readiness, and established the principles and operating model that let cross-functional teams co-create one plan: stage-specific, fit-for-purpose, and built around the decisions immediately in front of each program.
Outcome
A shared, decision-ready way of planning evidence that aligned functions around a single strategy and a single sequence, adopted as a discipline across the organization rather than a template that sat unused.
A patient-focused capability the organization kept.
Challenge
Patient input arrived episodically and often with a commercial cast, so it rarely shaped the development decisions that mattered, and patient-centricity stayed an aspiration.
Approach
I led an enterprise initiative to move patient-focused drug development from aspiration to operating model. I built the internal education, the cross-functional structures that carried patient insight through research, development, and commercialization, and the frameworks that let teams act on it, with the change management to make it hold.
Outcome
Patient evidence entered development as a standing capability rather than an episodic exercise, and the program's training core earned external industry recognition.
Real-world evidence that earned a place in the label.
Challenge
Real-world data had to meet the bar for a regulatory decision, in a submission where observational evidence had not been used before and weak design would not survive review.
Approach
I led the real-world evidence work behind the submission, designed to the reviewer's standard from the outset, on a cross-functional team working without a template for evidence of this kind.
Outcome
The evidence was accepted and cited in the product's approved label, the Summary of Product Characteristics, supporting a first-line expansion of the indication, and the review reached its outcome in a notably short timeframe. It stands as early work that helped establish how real-world evidence is built to survive regulatory scrutiny.
AI brought into evidence work, with judgment in charge.
Challenge
Generative and multi-agent AI promised speed in evidence generation, but speed that has not been tested against expert judgment does not survive scrutiny, and most claims went unproven.
Approach
I co-led and co-authored work bringing generative and multi-agent methods into core evidence workflows, from literature screening to cost-effectiveness modeling to health technology assessment briefing, each one validated against expert benchmarks before it was trusted, with senior judgment governing the calls a model should not make.
Outcome
Methods that reached expert-level agreement at a fraction of the time and cost, with the auditability a reviewer expects. Faster evidence a decision can still stand on.
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